MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Autoimmune Disorder (1732); Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Incontinence (1928); Itching Sensation (1943); Pain (1994); Skin Irritation (2076); Swelling (2091); Skin Inflammation (2443); Abdominal Distention (2601); Heavier Menses (2666); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain / lower left sided pelvic pain/pain') in a (b)(6)-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "right fallopian tube was open (at 3 months hsg test)".On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the patient experienced dermatitis ("dermatitis"), 2 months 16 days after insertion of essure.On (b)(6) 2017, the patient experienced cystitis ("bladder infection") with stress urinary incontinence.On an unknown date, the patient experienced pelvic pain (seriousness criterion medically significant), dermatitis contact ("cannot wear ¿fake¿ (or ¿costume¿) jewelry, which often has nickel in it, due to skin irritation and swelling/hypersensitivity symptoms"), abdominal pain ("constant abdominal pain"), oligomenorrhoea ("oligomenorrhea"), pruritus ("itching"), fatigue ("fatigue"), ear pain ("ear pain"), amenorrhoea ("having no period since (b)(6) 2013 / no menses for the past 4 months"), abdominal distension ("bloating"), musculoskeletal pain ("musculoskeletal pain"), genital haemorrhage ("abnormal bleeding") and autoimmune disorder ("auto-immune symptoms").The patient was treated with oral contraceptive nos.Essure treatment was not changed.At the time of the report, the pelvic pain, cystitis, dermatitis contact, abdominal pain, oligomenorrhoea, pruritus, ear pain, dermatitis, amenorrhoea, abdominal distension, musculoskeletal pain, genital haemorrhage and autoimmune disorder outcome was unknown.The reporter considered abdominal distension, abdominal pain, amenorrhoea, autoimmune disorder, cystitis, dermatitis, dermatitis contact, ear pain, fatigue, genital haemorrhage, musculoskeletal pain, oligomenorrhoea, pelvic pain and pruritus to be related to essure.The reporter commented: the plaintiff was assessed with recurrent lower quadrant pelvic pain of unclear etiology but noted possibility of being related to the essure implants.The plan is to proceed with laparoscopic bilateral salpingectomies with removal of the essure implants.Plaintiff still has the essure device surgically implanted and is presently seeking a physician who will remove them to address her symptoms.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: results: right fallopian tube was open; on (b)(6) 2013: results: bilateral tubal occlusion | no contrast spillage.Diagnostic results: on (b)(6) 2017, lab results indicated that she had a bladder infection.Plaintiff has not been tested for nickel allergy.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: pfs received : lawyer added, new event added-abnormal bleeding, auto-immune symptoms.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain / lower left sided pelvic pain/pain') in a 37-year-old female patient who had essure (batch no.975392) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "right fallopian tube was open (at 3 months hsg test)".On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the patient experienced dermatitis ("dermatitis"), 2 months 16 days after insertion of essure.On (b)(6) 2017, the patient experienced cystitis ("bladder infection") with stress urinary incontinence.On an unknown date, the patient experienced pelvic pain (seriousness criterion medically significant), dermatitis contact ("cannot wear ¿fake¿ (or ¿costume¿) jewelry, which often has nickel in it, due to skin irritation and swelling/hypersensitivity symptoms"), abdominal pain ("constant abdominal pain"), oligomenorrhoea ("oligomenorrhea"), pruritus ("itching"), fatigue ("fatigue"), ear pain ("ear pain"), amenorrhoea ("having no period since september 2013 / no menses for the past 4 months"), abdominal distension ("bloating"), musculoskeletal pain ("musculoskeletal pain"), genital haemorrhage ("abnormal bleeding") and autoimmune disorder ("auto-immune symptoms").The patient was treated with oral contraceptive nos.Essure treatment was not changed.At the time of the report, the pelvic pain, cystitis, dermatitis contact, abdominal pain, oligomenorrhoea, pruritus, ear pain, dermatitis, amenorrhoea, abdominal distension, musculoskeletal pain, genital haemorrhage and autoimmune disorder outcome was unknown.The reporter considered abdominal distension, abdominal pain, amenorrhoea, autoimmune disorder, cystitis, dermatitis, dermatitis contact, ear pain, fatigue, genital haemorrhage, musculoskeletal pain, oligomenorrhoea, pelvic pain and pruritus to be related to essure.No further causality assessment were provided for the product.The reporter commented: the plaintiff was assessed with recurrent lower quadrant pelvic pain of unclear etiology but noted possibility of being related to the essure implants.The plan is to proceed with laparoscopic bilateral salpingectomies with removal of the essure implants.Plaintiff still has the essure device surgically implanted and is presently seeking a physician who will remove them to address her symptoms.Right= 4 coils.Left= 4 coils.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: results: right fallopian tube was open; on (b)(6) 2013: results: bilateral tubal occlusion | no contrast spillage.Pregnancy test urine - on an unknown date: negative.Diagnostic results: on (b)(6) 2017, lab results indicated that she had a bladder infection.Plaintiff has not been tested for nickel allergy.Most recent follow-up information incorporated above includes: on 23-jun-2021: mr received.Reporter information , date of birth , lot number, lab data added and rcc was updated.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain / lower left sided pelvic pain/pain') in a 37-year-old female patient who had essure (batch no.975392) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the patient experienced dermatitis ("dermatitis"), 2 months 16 days after insertion of essure.On (b)(6) 2017, the patient experienced cystitis ("bladder infection") with stress urinary incontinence.On an unknown date, the patient experienced pelvic pain (seriousness criterion medically significant), dermatitis contact ("cannot wear ¿fake¿ (or ¿costume¿) jewelry, which often has nickel in it, due to skin irritation and swelling/hypersensitivity symptoms"), abdominal pain ("constant abdominal pain"), oligomenorrhoea ("oligomenorrhea"), pruritus ("itching"), fatigue ("fatigue"), ear pain ("ear pain"), amenorrhoea ("having no period since (b)(6) 2013 / no menses for the past 4 months"), abdominal distension ("bloating"), musculoskeletal pain ("musculoskeletal pain"), genital haemorrhage ("abnormal bleeding") and autoimmune disorder ("auto-immune symptoms").The patient was treated with oral contraceptive nos.Essure treatment was not changed.At the time of the report, the pelvic pain, cystitis, dermatitis contact, abdominal pain, oligomenorrhoea, pruritus, ear pain, dermatitis, amenorrhoea, abdominal distension, musculoskeletal pain, genital haemorrhage and autoimmune disorder outcome was unknown.The reporter considered abdominal distension, abdominal pain, amenorrhoea, autoimmune disorder, cystitis, dermatitis, dermatitis contact, ear pain, fatigue, genital haemorrhage, musculoskeletal pain, oligomenorrhoea, pelvic pain and pruritus to be related to essure.No further causality assessment were provided for the product.The reporter commented: the plaintiff was assessed with recurrent lower quadrant pelvic pain of unclear etiology but noted possibility of being related to the essure implants.The plan is to proceed with laparoscopic bilateral salpingectomies with removal of the essure implants.Plaintiff still has the essure device surgically mplanted and is presently seeking a physician who will remove them to address her symptoms.Right= 4 coils.Left= 4 coils.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: results: right fallopian tube was open; on (b)(6) 2013: results: bilateral tubal occlusion | no contrast spillage.Pregnancy test urine - on an unknown date: negative.Diagnostic results: on (b)(6) 2017, lab results indicated that she had a bladder infection.Plaintiff has not been tested for nickel allergy.Amendment: the report was amended for the following reason: event "right fallopian tube was open (at 3 months hsg test)" was deleted.No new follow-up information was received from the reporter.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain / lower left sided pelvic pain/pain') in a 37-year-old female patient who had essure (batch no.975392) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the patient experienced dermatitis ("dermatitis"), 2 months 16 days after insertion of essure.On (b)(6) 2017, the patient experienced cystitis ("bladder infection") with stress urinary incontinence.On an unknown date, the patient experienced pelvic pain (seriousness criterion medically significant), dermatitis contact ("cannot wear ¿fake¿ (or ¿costume¿) jewelry, which often has nickel in it, due to skin irritation and swelling/hypersensitivity symptoms"), abdominal pain ("constant abdominal pain"), oligomenorrhoea ("oligomenorrhea"), pruritus ("itching"), fatigue ("fatigue"), ear pain ("ear pain"), amenorrhoea ("having no period since (b)(6) 2013 / no menses for the past 4 months"), abdominal distension ("bloating"), musculoskeletal pain ("musculoskeletal pain"), genital haemorrhage ("abnormal bleeding") and autoimmune disorder ("auto-immune symptoms").The patient was treated with oral contraceptive nos.Essure treatment was not changed.At the time of the report, the pelvic pain, cystitis, dermatitis contact, abdominal pain, oligomenorrhoea, pruritus, ear pain, dermatitis, amenorrhoea, abdominal distension, musculoskeletal pain, genital haemorrhage and autoimmune disorder outcome was unknown.The reporter considered abdominal distension, abdominal pain, amenorrhoea, autoimmune disorder, cystitis, dermatitis, dermatitis contact, ear pain, fatigue, genital haemorrhage, musculoskeletal pain, oligomenorrhoea, pelvic pain and pruritus to be related to essure.The reporter commented: the plaintiff was assessed with recurrent lower quadrant pelvic pain of unclear etiology but noted possibility of being related to the essure implants.The plan is to proceed with laparoscopic bilateral salpingectomies with removal of the essure implants.Plaintiff still has the essure device surgically mplanted and is presently seeking a physician who will remove them to address her symptoms.Right= 4 coils.Left= 4 coils.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: results: right fallopian tube was open; on (b)(6)2013: results: bilateral tubal occlusion | no contrast spillage.Pregnancy test urine - on an unknown date: negative.Diagnostic results: on (b)(6) 2017, lab results indicated that she had a bladder infection.Plaintiff has not been tested for nickel allergy.Lot number: 975392 manufacture date: 2012-04 expiration date: 2015-04.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-jul-2021: quality safety evaluation of ptc.We received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 10513233
• MDR Text Key: 209355262
• Report Number: 2951250-2020-14096
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2015
• Device Model Number: ESS305
• Device Lot Number: 975392
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR